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This Notice is a time-sensitive Request for Information (RFI) inviting comments and suggestions on the barriers to reproducible research that are related to reagents and other relevant consumable research resources.

NOTE: It is important to read this entire RFI notice to ensure an adequate response is prepared and to have a full understanding of how your response will be utilized.

Many factors influence reproducibility in biomedical research; however, in discussions with stakeholders, one consistent concern that arises is the role reagents play in the reproducibility of research. Reagents include, for example, molecular and natural specimens (e.g., biospecimens, animal or human tissues, plant products or extracts), biochemical, biological, cellular, chemical, genomic, and/or immunologic resources integral to NIH supported research. Slight variations in quality, composition, reliability of preparation protocols, and accessibility of reagents have the potential to yield dramatic differences in the resulting data and conclusions. To ensure that rigorously designed and executed projects utilize the most effective and consistent reagents, the NIH seeks to understand and consider the various reagent-related challenges facing the research community. This request is intended to inform NIH efforts leading to more reproducible data on which to build future studies.

Information Requested

This RFI seeks input from stakeholders throughout the extramural community and the general public regarding the reagent-related barriers to reproducible biomedical research as it relates to 1) cell culture; 2) antibodies; 3) chemicals; 4) biospecimens; and 5) other research resources, whether commercial or custom made. Comment is sought for, but not limited to, the following general areas:

Experiences regarding variation in reagents/resources, including:

Barriers to identifying reagent composition and methods used to prepare, process, or store specific reagents

Documentation accompanying proprietary manufacturer-prepared kits

Characterization and/or validation of reagents/resources

Batch effects and variability of the same reagents’ performance between different labs and with storage time

Solutions to the following issues:

Common problems with reagents and techniques for developing and storing reagents

Needs for improved reagents or techniques for developing reagents, including the role of standard protocols

Actual or perceived barriers to improvements in reagent quality and accessibility

Needs for standardized terminology

The reagents, techniques, and tools used to improve reagent reproducibility and consistency, including barriers to use

The means by which students become trained in the consideration of reagent variability as a source of experimental irreproducibility and the processes to control it

Best practices for chain of custody procedures, such as – how reagents are handled, including packaging and temperature control during shipping, and stored from manufacture through use

Suggestions about best practices for sharing information, including:

Reporting of reagent or resource identification in publications

Changes in quality/activity of reagents

To ensure a thorough and comprehensive consideration of the aforementioned issues, information is sought for each of the considerations identified above and any other issues that may inform NIH’s efforts to address them. Your comments may include, but are not limited to:

Identifying the critical reagent-related barriers to reproducibility and their impact on biomedical research.

Information about your personal or institutional experiences in these areas that you believe would be useful to the NIH in understanding emerging or existing challenges.

How to Submit a Response

Responses (no longer than 3000 words in MS Word or pdf format) must be received by
5:00 pm (local prevailing time) on December 22, 2014. You will see an electronic confirmation acknowledging receipt of your response.

Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.

This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers. The Government will not pay for the preparation of any information submitted or for the Government’s use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government’s use of such information.